CBER cited Allergan for allegedly misbranding Botox by
advertising the product as "America's most popular cosmetic
treatment," although it is classified as a combination drug and
biologic product. Representing Botox as a cosmetic treatment
"minimizes the risks associated with the use of this biological
drug," the Warning Letter states. Furthermore, the FDA alleges that
Allergan minimized Botox's risk by adding the phrase "if any occur"
to the end of the fair balance statement in the journal ads, when
data show almost 50 percent of Botox patients experience some form
of adverse event associated with the biologic.

The FDA also objected to the ads for allegedly promoting Botox
as a way to reduce frown lines, although the product only is
approved for temporary improvement in the appearance of glabellar
lines -- wrinkles that form between the eyebrows. According to the
Warning Letter, Allergan previously agreed to modify this claim in
future ads in its Oct. 18, 2002, response to CBER. The FDA ordered
Allergan to immediately cease using the allegedly violative ads and
to provide a written action plan for disseminating corrective
information to those who might have seen the allegedly misleading
promotions.

For more details about the Botox Warning Letter and other
advertising enforcement news, see the August 2003 issue of the FDA
Advertising and Promotion Manual.